Business Model.

Market demand & drivers

TRENDING FOR THE NEXT DECADE AND LONGER...
"In this regard, longer-acting second generation products were introduced in Europe for both Eprex and Neupogen that require fewer administrations per course of treatment, provide quality and convenience advantages to patients and cost advantages to other health care cost components We found these longer-acting products had the largest market shares compared to first generation branded products and their biosimilars in all five countries." Health Affairs, Prof. Henry Grabowski*, Rahul Guha and Maria Salgado, June 2014 editionThe Hill/Congress Blog, June 5, 2014
"As the 79 million baby boomers march towards their 65th birthdays . . . there is an urgent need to effectively address the increasing prevalence of age-related illnesses . . ."
"The top health concerns of baby boomers include diabetes, cancer, heart disease, neurodegenerative diseases, arthritis, eye problems including macular degeneration, osteoporosis . . ." Susan Blumenthal, MD, Former U.S. Assistant Surgeon-Generalwww.huffingtonpost.com/susan-blumenthal/baby-boomers-health_b_843207.htm and www.scripps.org/news_items/4623-top-10-health-concerns-of-baby-boomers
THE DNX "CORE+" BUSINESS MODEL

DNX is committed to creating a low-overhead, semi-virtual operating environment that will not saddle DNX with high fixed costs.

STRATEGIC PARTNERSHIPS
TECHNOLOGY PLATFORMS & BENEFITS

Seamless Integration by DNX
DNX understands the practical implications of "horses-for-courses." Our in-depth knowledge of how proteins like to behave in different environments, combined with our Intellectual Property positions on products and processes, provides DNX the ability to match a particular protein drug to the correct drug enhancement and delivery platform. New compounds developed by DNX using 21st century half-life extension technology platforms are expected to provide improved therapeutic outcomes such as:

  • enhanced efficacy
  • fewer side effects
  • prolonged half-life (possibly up to monthly dosing)
  • enhanced stability
  • non-immunological response
  • new intellectual property positions

The Technology Platform
Polypeptide sequences composed of the amino acids Pro, Ala, and/or Ser ('PASylation') adopt a conformationally disordered bulky, solvated random coil structure that vibrate on a femto-to-picosecond basis, resulting in significant increases in hydrodynamic volumes. In structure, these sequences mimic the polymeric properties of polyethyleneglycol (PEG), but unlike PEG, PAS polypeptides are biodegradable and extraordinarily homogeneous, showing a single peak on ESI Mass Spectrometry. When attached to the biopharmaceutical of interest, the effective molecular weight of the combined entity can be tuned in a precise and pre-determined manner to bring about an extension in the circulation half-life of the protein by up to 2 orders of magnitude.

Modes of Use
Fusion: PASylation provides a simple way to attach a solvated random chain with large hydrodynamic volume to the protein of biopharmaceutical interest. The molecular biology-based fusion mode avoids the need for additional processing and purification steps due to the simple genetic fusion strategy, which permits biotechnological production and recovery together with the therapeutic protein as one single product. The fusion approach does not alter the cost of goods (COGS) parameter unlike in the case of conjugation coupling modes.

Branched: The PAS polymer sequences exhibit lower viscosities than the corresponding PEG polymers. This major advantage allows the use of PAS sequences in branched modes. For example, PAS sequences can be attached via gene fusion to either the N-terminus, the C-terminus or to both termini of a recombinant protein and have the resulting entity be produced in an integral manner as one single product, with a lower viscosity effect than alternative conjugation-based half-life extension technologies.

Conjugation: In certain circumstances, it may be necessary to use a chemical coupling approach to modifying the half-life of a biopharmaceutical protein rather than a fusion strategy. This may be true for example, in situations related to favorably extending the long-term fade rate of an existing product. PAS polymers have been designed for potential chemical conjugation strategies. While there would certainly be a COGS consideration, the potential benefit from being able to extend the long-term fade rate of an important commercial molecule may well outweigh such concerns.